Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma
- Registration Number
- NCT01082809
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma
- Detailed Description
Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- age ≥ 18
- histologically or cytologically confirmed adenocarcinoma of biliary tract
- unresectable or metastatic
- ECOG performance status of 0~2
- measurable or evaluable lesion per RECIST criteria
- adequate marrow, hepatic, renal and cardiac functions
- One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
- provision of a signed written informed consent
Exclusion Criteria
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids
- known history of hypersensitivity to study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sunitinib Sunitinib Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle
- Primary Outcome Measures
Name Time Method Time to progression 12months
- Secondary Outcome Measures
Name Time Method Safety profile 12 months Response rate 12 months Duration of response 12 months Overall survival 12 months Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations 12 months
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of